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Moderated conference on GMOs in the pipeline, hosted by the FAO Biotechnology Forum in 2012

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Biotech-Mod2 <[log in to unmask]>
Mon, 3 Dec 2012 18:51:35 +0100
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This is Henry Clifford again, and I would like to respond to some of the questions and comments posted in Messages 89 and 90.

In Message 89, Professor Baba asked: "I am interested in the postings of Henry Clifford with respect to AquAdvantage Salmon and its production in cold freshwater. How can the production of this genetically modified salmon be exported and facilitated under controlled conditions in tropical environments? Are there GM freshwater fish in the pipeline?"
  
AquAdvantage Salmon was intended to be grown entirely in fresh water, from egg to harvest. (Most species of salmon will grow and thrive very well in fresh water, and do not require saltwater for normal metabolic processes; they migrate to the ocean generally because of superior dietary options which the marine environment offers.) In fact the formal conditions of use in our FDA application state that AquAdvantage Salmon must be reared entirely in freshwater. There are many tropical countries, which in spite of their latitude, possess highlands and mountainous regions which offer ideal temperature regimens for coldwater fish such as salmon and trout. Therefore, yes, AquAdvantage Salmon is a "GM freshwater fish in the pipeline." It is my understanding, that with the exception of several ongoing projects in China, there are no other GM freshwater fish intended for human consumption in the pipeline other than AquaBounty's salmonids. But I welcome comments or information from others who are currently working with GM freshwater fish. 
 
In Message 90, Dr. Scotto asked a number of questions:

1. "The biotechnology has therefore developed GM fish for nearly 30 years, but so far we have not seen any GM fish commercialized in market. Why not yet? And if not sold in the countries that were developed. Why would that be in developing countries in the future?"

I cannot speak for other developers, but in the case of AquAdvantage Salmon, when the salmon was ready for regulatory review, the appropriate regulatory authority in the USA (FDA) did not have a formal, published regulatory process for review and approval of GM animals intended for human consumption. Considerable time and effort by the FDA was required for them to develop and formalize their regulatory guidelines. Some of the requirements of the FDA regulatory review process, for example demonstrating durability and heritability of the transgene over multiple consecutive generations of the GM animal, cannot be "shortened in time", and in the case of animals with relatively long life cycles, such as cold water fish, require many years to complete just that one study. In the case of AquAdvantage Salmon, the goal is to produce eggs in a developed country, sell those eggs to local fish farmers in a developing country (in Central America) who will benefit from being able to produce a low cost, nutritious, high protein food, which can then be sold and consumed locally in the developing country, or exported (generating hard currency export income) to the USA, which is one of the largest markets for salmon in the world. 
 
2. "Question: How do you ensure that no low fertility male fish mixed with sterile females in these large batches of transgenic fish?"

Populations of 100% all female AquAdvantage Salmon are produced using neomales (males which are genetically female), which assures that no male chromosomes are present in either the eggs or milt. No male fish can result from this methodology.
 
3. "Question: If the sterile transgenic fish is why many take containment measures for their safety? Would it work these measures and biosecurity protocols in developing countries where environmental accidents are very common and some punished?"

The ideal biosecurity plan for GM fish is a multi-layered, redundant strategy that combines biological containment (sterility, all female), physical containment (screens, nets, filters, containment devices), and ecological containment (thermal barriers, competitive disadvantages) in one overall master biosafety plan. In the event that one of the containment layers fails, the other containment measures succeed in confining the fish and preventing its proliferation. And most definitely these measures will function well in developing countries, precisely for the reason that there are simultaneous, redundant, multiple containment elements at work, in the event of a human error. Proof of this is our successful containment track record in Central America.  
 
4. "Have social acceptability or license before being introduced or developed locally. What do you want? What is needed?"

You should pose this question to fish farmers in developing countries. Ask them if they would like to switch from their current fish culture candidate to a faster growing version which can be grown sustainably at a lower cost, and provide high value, nutritious, high protein food, for local consumption and/or export. I suspect that they will say "yes".
 
5. "Question: In the case of Peru, this natural thermal barrier would not exist, since it would foster conditions in cold rivers (Peruvian Andes). And if it escapes to the sea, the temperature conditions are too cold, so this environmental containment barrier does not exist as the proposal for Panama."

As I stated in Message 74, there is only one country currently under consideration as an FDA approved growout site for AquAdvantage Salmon, and it is in Central America. If we proposed production at another growout site, for example Peru, we would have to submit to the FDA a supplemental application in which a risk analysis of the newly proposed site is examined. Only after FDA approval of the second site, would we even allow AquAdvantage Salmon to be produced there. To specifically answer your question: as described in item 3 above, the other biological and physical and ecological containment layers would function well in the absence of a thermal barrier. 
 
6. "If GM fish escaped from fish farms, they could further upset the oceans' delicate ecology, causing ecological disruption or species extinction."

I cannot speak for other GM fish, but considering the multiple, redundant biological, physical, and ecological containment barriers built into AquAdvantage Salmon and their proposed rearing systems, the risk of them reaching the ocean in sufficient, self-sustaining quantities to "upset the ocean's delicate ecology" is essentially zero. And when you refer to "species extinction", if you are attempting to invoke the Trojan Gene Theory, I suggest you consult with the founder of the theory (Dr. Bill Muir) and his publications to understand why that theory would not apply to our salmon.
 
7. "The question is not whether such risks are acceptable, but if needed in some way to our realities in the future. Continually remind us of the need to feed the world or fill a need beyond our reality with transgenesis, stating that we must necessarily risk. Should we evaluate previously unhurried and cautious way...!"

The "need to feed the world" is not a trivial matter, which can afford to wait another 50 years while disciples of the precautionary principle anguish over attempts to identify and quantify every known or imaginable risk in innovative food production technologies. Organizations which automatically oppose incorporation of innovative biotechnologies such as GM foods in food production and rarely offers viable alternative options for how we are going to feed 9 billion people by 2050, are performing an alarming disservice to humanity, particularly in developing countries, where malnourishment and starvation is a pressing concern. 

Henry C. Clifford
Vice President of Marketing & Sales
AquaBounty Technologies
San Diego, 
California 92121
United States
Tel: 858 450-9487
Fax: (858) 450-9519
Email: hclifford (at) aquabounty.com
www.aquabounty.com

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